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Atomoxetine in Patients With Tourette's Syndrome (ATO-TS)

Primary Purpose

Tourette Syndrome

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Atomoxetine

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Impulsivity

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine
The use of effective contraception or abstinence for subjects of reproductive age
Written informed consent

Exclusion Criteria:

Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria.
Actual severe depression
Allergy to one of the constituents
Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma
IMAO treatment discontinued less than 2 months or contra-indicated associated treatment

Sites / Locations

CHU PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with Tourette's syndrome

Arm Description

Atomoxetine in Patients With Tourette's Syndrome

Outcomes

Primary Outcome Measures

Impulsive state

The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)

Secondary Outcome Measures

Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance

The secondary outcomes are the effects of Atomoxetine in cognition, anxiety, depression, severity of tics and compulsive disorders, as mesured with autoquestionnaries. The investigators also evaluate the tolerance of chronic administration of atomoxetine in patients with Tourette's syndrome.

Full Information

NCT ID

NCT04354103

First Posted

April 7, 2020

Last Updated

June 12, 2023

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04354103

Brief Title

Atomoxetine in Patients With Tourette's Syndrome

Acronym

ATO-TS

Official Title

A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 31, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.

Detailed Description

High impulsivity characterizes severe forms of Tourette's syndrome, in which motor and vocal tics are associated with various neuropsychiatric disorders as compulsive disorders, difficult to manage and impairing quality of life of patients and their family. Previous preclinical study and clinical studies in attention-deficit hyperactivity disorder and Parkinson's disease demonstrate that atomoxetine, a selective noradrenaline reuptake inhibitor, improves response inhibition in high impulsive individuals. However, there is no suffisant data in Tourette's syndrome. The purpose of this pilot study is to evaluate the effects of Atomoxetine on impulsivity in 10 to 35 years old patients with Tourette's syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette Syndrome

Keywords

Impulsivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients with Tourette's syndrome

Arm Type

Experimental

Arm Description

Atomoxetine in Patients With Tourette's Syndrome

Intervention Type

Drug

Intervention Name(s)

Atomoxetine

Intervention Description

Atomoxetine

Primary Outcome Measure Information:

Title

Impulsive state

Description

The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine The use of effective contraception or abstinence for subjects of reproductive age Written informed consent Exclusion Criteria: Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria. Actual severe depression Allergy to one of the constituents Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma IMAO treatment discontinued less than 2 months or contra-indicated associated treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Solene ANSQUER, MD, PhD

Phone

0549444387

solene.ansquer@chu-poitiers.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Luc HOUETO, MD, PhD

Phone

0549444446

jean-luc.houeto@chu-poitiers.fr

Facility Information:

Facility Name

CHU Poitiers

City

Poitiers

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Solene ANSQUER

Phone

0549444387

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24252357

Citation

Ansquer S, Belin-Rauscent A, Dugast E, Duran T, Benatru I, Mar AC, Houeto JL, Belin D. Atomoxetine decreases vulnerability to develop compulsivity in high impulsive rats. Biol Psychiatry. 2014 May 15;75(10):825-32. doi: 10.1016/j.biopsych.2013.09.031. Epub 2013 Oct 11.

Results Reference

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PubMed Identifier

17644072

Citation

Chamberlain SR, Del Campo N, Dowson J, Muller U, Clark L, Robbins TW, Sahakian BJ. Atomoxetine improved response inhibition in adults with attention deficit/hyperactivity disorder. Biol Psychiatry. 2007 Nov 1;62(9):977-84. doi: 10.1016/j.biopsych.2007.03.003. Epub 2007 Jul 17.

Results Reference

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PubMed Identifier

24893708

Citation

Kehagia AA, Housden CR, Regenthal R, Barker RA, Muller U, Rowe J, Sahakian BJ, Robbins TW. Targeting impulsivity in Parkinson's disease using atomoxetine. Brain. 2014 Jul;137(Pt 7):1986-97. doi: 10.1093/brain/awu117. Epub 2014 Jun 3.

Results Reference

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PubMed Identifier

16380617

Citation

Allen AJ, Kurlan RM, Gilbert DL, Coffey BJ, Linder SL, Lewis DW, Winner PK, Dunn DW, Dure LS, Sallee FR, Milton DR, Mintz MI, Ricardi RK, Erenberg G, Layton LL, Feldman PD, Kelsey DK, Spencer TJ. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology. 2005 Dec 27;65(12):1941-9. doi: 10.1212/01.wnl.0000188869.58300.a7.

Results Reference

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Atomoxetine in Patients With Tourette's Syndrome

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